Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim status
Claims 16-18, 21-28 are pending.
Claims 1-15 are canceled.
Claims 16 and 18 are amended.
Claims 21-29 are new.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-18 and 21-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) “use one or more artificial intelligence techniques to identify the virus based on a model that classifies viruses based on virus strain clusters.”
Claim 16 recites “receive the spectra data” and “identify the virus based on a model that classifies viruses based on virus strain clusters”. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed via a computer (MPEP 2106.04(a)(2) section Ill). The limitations stated above as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, other than “computer device” and “spectrometer”, nothing in the claim element precludes the steps from practically being performed in the mind.
Further, this judicial exception is not integrated into a practical application. The claim recites “receive” and “identify” steps. The courts have indicated that gathering and analyzing information using conventional techniques and displaying the result is not sufficient to show an improvement to technology. MPEP 2106.05(a)(II) (discussing TLI Communications LLC V. AV Auto., LLC, 823 F.3d 607, 612-13 (Fed. Cir. 2016)). Hence, the claim is not patent eligible based on the above reasoning and rationale.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a substrate with a particle precursor, vertically-aligned carbon nanotube (CNxCNT) array on the substrate, and plurality of carbon nanotubes with inter-tubular distance between them and at least one with enriching particles, are well understood, routine, and conventional within the prior art (see e.g., Chen et. al. (US20140030788)). Therefore, this claim is not patent eligible.
Dependent claims 17, 18, and 21-28 are rejected as being dependent on independent claim 16.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-18 and 21-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "at least one nanotube" in line 9. It is unclear whether the limitation is referring to the carbon nanotube(s) previously recited in the claim, or a different nanotube. The limitation will be interpreted as “at least one carbon nanotube of the plurality of carbon nanotubes” for consistency and clarity.
Dependent claims 17, 18, and 21-28 are rejected as being dependent on claim 16.
Claims 16-18 and 21-28 are indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Attempts to claim a process without setting forth any steps involved in the process raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 16 recites the limitation “use one or more artificial intelligence techniques to identify the virus based on a model that classifies viruses based on virus strain clusters”. This limitation is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Specifically, without positively reciting the comparison step in the claim, it is unclear how the virus is identified using the model (see applicant’s specification, para [0059]). Further, the relationship between the artificial intelligence and claimed model, or how information from the model is obtained, is unclear as claimed.
See Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986) (a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced). See MPEP 2173.05(q).
Dependent claims 17, 18, and 21-28 are rejected as being dependent on claim 16.
Claim 22 recites “machine learning technique includes use of a classification model based on a three-fold cross-validation assessment of a logistic regression model, a support vector machine model, a decision tree model, and a random forest model”. This limitation is indefinite since, as mentioned above, it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
In particular, without positively reciting the relationship between the system and machine learning technique to the classification model based on a three-fold cross-validation, it is unclear how the assessment is performed. In addition, the relationship between the system and the four models (i.e., logistic regression model, a support vector machine model, a decision tree model, and a random forest model) is unclear. Paras [0059] and [0077] of applicant’s specification discloses that the three-fold cross-validation is used to develop a machine learning strategy and differentiates between viruses in addition to spectra.
Claim 23 recites “wherein the model uses a fingerprint for each virus strain to classify viruses, the fingerprint based on over 100 spectra for each virus strain of a plurality of virus strains”. As mentioned above, this limitation is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. In particular, without positively reciting the correlation of the fingerprint to the model and the comparison step, it is unclear how the virus strain is classified (see Spec., Para [0059]). See MPEP 2173.05(q).
Claim 24 recites “such that the system is able to detect viruses on a picomolar scale”. This limitation is indefinite as it does not clearly define the meets and bounds of the claim. The steps of how the detection of the virus on a pictomolar scale is performed are not positively recited in the claim.
Claim 29 recites “wherein the classified virus is used for virus isolation, immuno- staining, and/or next-generation sequencing.” This limitation is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. In particular, the steps of how a classified virus is subsequently used for isolation, immune-staining, and next generation sequencing is not recited in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16-18, 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et. al. (US20140030788) and further in view of Gardner (US20070216898).
Regarding Claim 16, Chen teaches “a bioagent capture and identification system,” (Abstract, Paras [0002], [0006], and [0043], Systems relating to the manipulation of particles including biological particles and a fluidic capture. Also used to facilitate complete lab-on-chip assays for partial identification by providing the efficient capture of specific bioparticles.); “comprising: a microfluidic device,” (Para [0079], microfluidic device); “comprising: a substrate;” (Para [004], microfluidic devices include obstacles coated with binding moieties that selectively bind to specific bioparticles that contact surfaces of the obstacle. In some situations, the obstacles are formed from solid materials such as silicon, polymers, and glass.); “and a vertically-aligned carbon nanotube (CNxCNT) array grown on the substrate, the CNxCNT array comprising a plurality of carbon nanotubes” (Para [0008] and Abstract, Each obstacle can include multiple, generally aligned, e.g., vertically aligned, nanostructures, such as nanotubes or nanorods, e.g., carbon nanotubes or nanorods.); “the CNxCNT array comprising a plurality of carbon nanotubes having an inter-tubular distance the inter-tubular distance being a distance between one carbon nanotube and another carbon nanotube for each carbon nanotube of the plurality of carbon nanotube;” (Para, [0135, Each nanostructure is positioned relative to an adjacent nanostructure at a distance so as to together define an average distance between adjacent nanostructures. In some embodiments, the average distance between adjacent nanostructures is roughly equal for each nanostructure. In other embodiments, the distances between adjacent nanostructures may vary.); “wherein the substrate is patterned with a particle precursor;” (Para [0229], In some cases, the nanostructures may be grown on a substrate. In some embodiments, the nanostructure precursor material may be a nanotube precursor material and may comprise one or more fluids, such as a hydrocarbon gas, hydrogen, argon, nitrogen, combinations thereof, and the like.); “wherein at least one nanotube is decorated with an enriching particle;” (Para [0185] and [0041], components of fluids, thereby offering mechanisms of enriching or otherwise processing such components. The combination of patterned permeable nanostructure provide significant advantages and benefits in methods of isolating, and enriching,).
The recitation “and wherein the microfluidic device is configured to receive a solution containing a virus and capture the virus within the inter-tubular distance between two carbon nanotubes based on size;” is capability of the microfluidic device. Chen discloses the positively claimed structural elements of the microfluidic device as claimed, such microfluidic device is said to be fully capable of the recited adaption in as much as recited and required herein. In addition Chen teaches a micro-channel that flows a solution (Para [0269], teaches a solution flowed through a micro-channel) and capturing between the distance of two carbon nanotubes (Paras [0006], [0026], [0152] and [0191], gap size between the obstacles and the shape of the obstacles (formed of multiple aligned nanostructures) can be optimized to ensure fast and efficient filtration. Smaller gap sizes ensure more efficient capture of WBCs, but also a slower rate of passage for the RBCs and platelets. Depending on the type of application different geometries can be used. The second type of particles can be, for example, viruses, viral particles, exosomes, microvesicles, nucleic acids, proteins, lipids, and synthetic nanoparticles.) Therefore the solution is capable of being a virus.
Further taught by Chen is “and a spectrometer” (Para [0039], The detecting device can be, for example, a microscope, a particle counter, a magnet, a biocavity laser, a mass spectrometer). The recitation “configured to generate spectra data of the captured virus;” is capability of the spectrometer. Chen discloses the positively claimed structural elements of the spectrometer, such spectrometer are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Chen teaches a hyperspectral imaging system (Para [0039], hyperspectral imaging system). Hyperspectral imaging systems generate spectra data.
Chen does not explicitly teach “a computer system comprising a computer device and a database, the computer system configured to receive the spectra data and use one or more artificial intelligence techniques to identify the virus based on a model that classifies viruses based on virus strain clusters.”. But does teach a computer terminal (Para [0247]- a computer terminal can be connected to the detection module.).
Gardner teaches a bioagent detector and methodology in addition to teaching “a computer system comprising a computer device and a database” (Paras [0077], [0084], and [0147], on-board computer 1974 may read the detector output and the acquired spectrum may then be processed, searched against an internally-stored library of spectra in memory device 1972, and the results displayed to an operator on a display unit 1976.). The recitation “configured to receive the spectra data and use one or more artificial intelligence techniques to identify the virus based on a model that classifies viruses based on virus strain clusters.” is capability of the computer system. However, it is also taught by Gardner in (Para [0147], as stated above).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teachings of Gardner wherein the system has a computer system comprising a computer and a database and the system is configured to receive spectra and match to other spectra in the database to make an identification. Doing so would allow the system to be fulling functioning on its own from capturing to identification. Reduces the need outside devices to be attached and additional libraries of databases to be purchased to make and identification.
Regarding claim 17, modified Chen teaches all of claim 16 as above but does not teach “wherein the spectrometer is a Raman spectrometer.”.
Gardner further teaches “wherein the spectrometer is a Raman spectrometer.” (Para [0017], biological detection system relies on multi-point imaging Raman spectroscopy.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Chen to incorporate the teachings of Gardner wherein the spectrometer is Raman spectrometer. Doing so would provide a spectrometer that is non-destructive to the sample while also providing detailed molecular structure information fast.
Regarding claim 18, modified Chen teaches all of claim 16 as above. Modified Chen does not explicitly teach “wherein the database includes historical spectra data of different viruses.” However it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Chen wherein the database includes historical spectra data of different species since Gardner teaches the spectra is searched against an internally stored library of spectra in a memory device (Para [0147] the acquired spectrum may then be processed, searched against an internally stored library of spectra in memory device 1972). Having a library of spectra that is stored in memory would include spectra that was previously run and stored in the memory which is historical by nature. Having a library that houses spectra used to search against teaches different species within the database.
Regarding claim 21, modified Chen teaches all of claim 16 above. The recitation “wherein the one or more artificial intelligence techniques includes machine learning.” is capability of the computer system. Modified Chen discloses the positively claimed structural elements of the computer system as claimed, such computer system is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 22, modified Chen teaches all of claim 17 above. The recitation “wherein the machine learning technique includes use of a classification model based on a three-fold cross-validation assessment of a logistic regression model, a support vector machine model, a decision tree model, and a random forest model.” is capability of the computer system. Modified Chen discloses the positively claimed structural elements of the computer system as claimed, such computer system is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 23, modified Chen teaches all of claim 16 above. The recitation “wherein the model uses a fingerprint for each virus strain to classify viruses, the fingerprint based on over 100 spectra for each virus strain of a plurality of virus strains.” is capability of the computer system. Modified Chen discloses the positively claimed structural elements of the computer system as claimed, such computer system is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 24, modified Chen teaches all of claim 17 as above. Chen does not specifically teach “wherein Raman signals generated from the Raman spectrometer”.
Gardner teaches “wherein Raman signals generated from the Raman spectrometer” (Para [0002] Spectroscopic imaging combines digital imaging and molecular spectroscopy techniques, which can include Raman scattering, fluorescence, photoluminescence, ultraviolet, visible and infrared absorption spectroscopes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to corporate the teachings of Gardner wherein Raman signals generated from the Raman spectrometer. Doing so increases the detection timing.
Chen further teaches “are enhanced due to the at least one nanotube being decorated with the enriching particle” (Para [0185] and [0041], components of fluids, thereby offering mechanisms of enriching or otherwise processing such components. The combination of patterned permeable nanostructure provides significant advantages and benefits in methods of isolating, and enriching,).
The recitation “such that the system is able to detect viruses on a picomolar scale.” is intended use of the system. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Regarding claim 25, modified Chen teaches all of claim 16 as above. The recitation “wherein the virus includes low pathogenic avian influenza virus (LPAIV) and/or RNA virus.” is intended use of the apparatus. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Regarding claim 26, modified Chen teaches all of claim 16 as above. The recitation “wherein the system is configured to identify the virus without use of a bench top procedure and without use of a labeling technique” is capability of the system. Modified Chen discloses the positively claimed structural elements of the system as claimed, such system is said to be fully capable of the recited adaption in as much as recited and required herein. Further Gardner teaches not using a bench top within (Para [0134], It can be readily seen that such devices are compact and while having a small optical path (measured between the sample and the detector) can be as efficient as the table-top units.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to corporate the teachings of Gardner wherein the system does not use a bench top. Doing so would allow the device to be portable and increase ease of use.
Regarding claim 27, modified Chen teaches all of claim 16 as above. The recitation “wherein the system is configured to identify the virus without use of an antibody as a label.” is capability of the system. Modified Chen discloses the positively claimed structural elements of the system as claimed, such system is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 28, modified Chen teaches all of claim 16 as above. The recitation “wherein the system is configured to identify the virus without use of a primer as a label.” is capability of the system. Modified Chen discloses the positively claimed structural elements of the system as claimed, such system is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 29, modified Chen teaches all of claim 16 as above. The recitation “wherein the classified virus is used for virus isolation, immuno- staining, and/or next-generation sequencing.” is intended use of the apparatus. Therefore, the prior art teaches to all of the positively claimed limitations and can function as intended to.
Response to Amendments
Claim Amendments
The claim objection set forth in the office action of 06/18/2025 is resolved by applicant’s submission on 12/17/2025.
Applicants’ amendments to claim 16 overcome the previous 112 rejection.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered.
Applicant argues that Chen and Gardner are devoid of any discussion of classifying viruses based on strain clusters.
Examiner notes that the virus as claimed is capability of the device. The recitation “configured to receive a solution containing a virus” is capability. Chen’s system receives a solution and therefore capable of receiving a virus and classifying a virus based on strain clusters since. The solution within Chen is capable of being a virus in addition to Chen referencing particles can be, for example, viruses, viral particles. As the prior art provides to commensurately disclose the positively claimed system elements of the system as claimed, such system is said to be fully capable of classifying viruses based on strain clusters in as much as recited and required herein.
Applicant recites there is no discussion within Chen or Gardner related to detecting viruses on a picomolar scale or detecting viruses without the use of bench top procedures or labeling techniques. There are no technical features disclosed by that that would facilitate such operation.
Examiner highlights that all of these are capability of the system and therefore modified Chen is capable of such capability as the positively claimed limitations are taught.
Applicant argues the techniques of Chen and Gardner are not capable of providing the technical results Applicant's technology is able to generate.
Examiner disagrees and states that modified Chen teaches receiving a solution which is capable of having a virus. Further Gardner teaches not using a bench top within (Para [0134], It can be readily seen that such devices are compact and while having a small optical path (measured between the sample and the detector) can be as efficient as the table-top units.). Therefore, modified Chen teaches the capability of detecting viruses on a picomolar scale or detecting viruses without the use of bench top. Modified Chen teaches all of the positively claimed limitations and is capable of the capability and intended use as recited within the present claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798